Covid19
Conditions
Brief summary
A Phase I/II clinical trial for safety and efficacy evaluation of treatment with anti-SARS-CoV-2 equine immunoglobulin (F(ab')2) in hospitalized patients with COVID-19 not requiring of invasive ventilation support.
Interventions
BIOLOGICALAnti-SARS-CoV-2 immunoglobulin
Treatment with Anti-SARS-CoV-2 immunoglobulin
Sponsors
D'Or Institute for Research and Education
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Inpatients diagnosed with COVID-19 by RT-PCR; * Time between symptom onset and inclusion ≤ 10 days; * Age ≥ 18 years and \<75 years * No indication of invasive ventilatory support at the time of randomization; * Signature of the Informed Consent Form.
Exclusion criteria
* Pregnant or lactating women * Severe comorbidity: Severe heart disease, severe COPD or O2-dependent COPD, terminal cancer. * Any confirmed or suspected immunosuppressive or immunodeficiency state, including HIV (regardless of treatment, CD4 count or viral load status); asplenia; severe recurrent infections and chronic use (more than 14 days) of immunosuppressive medication in the last 6 months, except for topical steroids or short-term oral steroids (cycle lasting ≤14 days); * History of anaphylaxis or severe allergic reaction; * Previous use of any heterologous serum; * Participation in trials of prophylactic drugs or vaccines for COVID-19; * Administration of immunoglobulins and / or any blood products in the previous three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of adverse events related to the infusion of anti-SARS-CoV-2 immunoglobulin through CTCAE v4.0. | 28 days |
| Clearence of viral RNA evaluated by RT-PCR | 72 h |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of viral load evaluated by area under the curve of RT-PCR values | Day 0, Day 3, Day 7 and Day 14 | Viral load reduction evaluated by area under the curve of RT-PCR values |
| Length of hospital stay | For as long as the duration of the hospital stay | number of days between admission and discharge |
| Orotracheal Intubation Rate | 28 days | Number of patients who progressed to the use of invasive mechanical ventilation and require orotracheal intubation throughout hospitalization |
| Infusional reaction rate | 28 days | number of patients who experienced adverse events after the immunoglobulin infusion |
| Mortality rate | 28 days | number of deceased patients |
| Assessment of adverse events | 28 days | Frequency of adverse events classified following CTCAE |
| Evaluation of clinical status | Day 0, Day 14, Day 21 and Day 28 | Results of a 7-point ordinal severity scale |
| Modulation of serum and cellular inflammatory marker | Day 0, Day 3 and Day 7. | Exploratory analysis of the variation of inflammatory markers by ELISA/Luminex and flow cytometry, compared to baseline levels |
Outcome results
None listed